Ileostomy and like appliances

ABSTRACT

This application discloses a care-free all plastic, substantially weightless, pliable yet protective ileostomy appliance consisting of a nylon outer plate which fits over a disposable expanded polystyrene inner disc. The disc is held against the skin surrounding a stoma and a disposable plastic pouch is clamped between the plate and the disc. The inexpensive daily disposable disc is provided with indented sides and the plate with registering slots. Each end of a belt enters a slot from beneath and loops back over the plate to retain the appliance in position.

United States Patent [72] In n R l-lauser 3,283,757 11/1966 Nelsen... 128/283 Eatontown,N.J. (2151 E. Lincoln Hwy. 3,351,061 1 H1967 Nolan 128/283 Apt. D-lO Levittown, Pa. 19056) FOREIGN PATENTS [21] 839 818 6/1960 Great Britain 128/283 [22] 1967 975,392 11/1964 Great Britain... 128/283 [45] Paemed 1971 1,021,145 3/1966 Great Britain 128/283 Primary Examiner-Charles F. Rosenbaum [54] ILEOSTOMY AND LIKE APPLIANCES A"omey Lucke and Lucke 7 Claims, 17 Drawing Figs. [52] 128/283 [51] 5/44 ABSTRACT: This application discloses a care-free all plastic, [50] 128/283 substantially weightless, pliable yet protective ileostomy appliance consisting of a nylon outer plate which fits over a [56] References Cited disposable expanded polystyrene inner disc. The disc is held UNITED STATES PATENTS against the skin surrounding a stoma and a disposable plastic 2,910,065 10/1959 Marsan 128/283 pouch is clamped between the plate and the disc. The inex- 3,040,745 6/1962 Tezak 128/283 pensive daily disposable disc is provided with indented sides 3,043,306 7/1962 Hergatt et aL. 128/283 and the plate with registering slots. Each end of a belt enters a 3,100,488 8/1963 Orowan 128/283 slot from beneath and loops back over the plate to retain the 3,221,742 12/1965 Orowan 128/283 appliance in position.

iv 4 A l l l l .l 35 34 22 37 32 PATENTED M26197: 3551790 sum 2 or 3 l v 1 I l ilill .|:1

Raul C Hauser ILEOSTOMY AND LIKE APPLIANCES BACKGROUND OF THE INVENTION 1. Field of the invention This invention relates to ileostomy, colostomy, cestosomy temporary postoperative appliances and permanent management systems which are attached to the body of a patient to collect the fecal discharge from a stoma.

2. Description of the prior art Conventional appliances and systems employ hard rubber or plastic face plates which are cemented to the skin surrounding a stoma with liquid glue. Most of these appliances are permanent in nature and use metal or rigid plastic parts to lock the receptive opening of a pouch into proper position. These uncomfortable, harder and heavier members which are replaceable when worn, but not disposable on a daily basis, are strapped into place by an expandable cloth or rubber belt with metal buckles or other metal fastening devices.

The most economical pouches are fitted with conventional tail spouts and are reuseable. They require thorough washing, soaking, deodorizing, airing, drying, etc. before each reuse. Known vinyl disposable pouches are not only more expensive per se than the reusable bags and other disposable plastic bags disclosed herein, but require a constant supply of costly chemical aids. None of the prior art disclose an appliance wherein the soilable back piece adjacent the skin is disposable on a daily basis.

SUMMARY OF THE INVENTION According to the present invention a body conforming inner thermoplastic disc made of expandable polystyrene, in either the small or large bead, can be readily molded to the desired size and shape of that part of a patients anatomy surrounding a stoma. The oval disc can be fabricated from a mold placed in a steam chest into a variety of standard overall sizes and shapes with center portions of different diameters to define central holes large enough to accommodate various sizes of stomas.

The outer size and shape of a nylon plate will conform to that of its inner disc. A raised ring or curved flange defining the center hole of the plate will fit snugly over a second raised ring or curved flange disposed on the outer surface of the disc to clamp a flat collar attached to the receptive opening of a plastic pouch therebetween.

The appliance will include a supply of various pull-off two sided pressure sensitive strips in various shapes and sizes to adhere the disc to the skin and the bag to the disc.

BRIEF DESCRIPTION OF THE DRAWINGS Further features and advantages of the invention will be apparent in the following detail description and the accompanying drawings which illustrate preferred embodiments of the invention, wherein:

FIG. 1 is a top plan view of the bottom or inner disc of an appliance forming the invention adapted for use in servicing ileostomy and/or small colostomy conditions;

FIG. 2 is a sectional view of the disc taken along line 2 2-2 of FIG. 1;

FIG. 2a is an elevational view, partially broken away, of the rimmed disc with a larger center hole than that shown in FIGS. 1 and 2;

FIG. 3 is a plan view of the upper or outer plate;

FIG. 4 is a sectional view of the plate taken along line 4-4 of FIG. 3;

FIG. 5 is a sectional elevational view of the assembled appliance shown in FIGS. l4;

FIG. 6 is a top plan view of a horizontally elongated bottom or inner disc of an appliance adapted for use on a person who had a temporary colostomy and has a double stoma in a horizontal position;

FIG. 7 is an elevational view, partly in section, of the assembled appliance formed from the members shown in FIGS. 6 and 8, including the disc taken on line 7'7 of FIG. 6;

FIG. 8 is a plan view of the slotted upper or outer plate which fits over the disc shown in FIG. 6 and the manner in which both ends of the belt are fed through its slots from the rear of the plate and looped back over the top of the plate; FIG

FIG. 9 is a top plan view of a vertically elongated bottom or inner disc of an appliance adapted for use in servicing temporary colostomy patients who have double stomas in a vertical position;

FIG. 10 is a sectional view of the disc shown in FIG. 9 taken on line 10-10;

FIG. 11 is a sectional view of the disc shown in FIG. 9 taken on line 11-11;

FIG. 12 is a plan view of the slotted upper or outer plate which fits over the rimmed disc shown in FIG. 9;

FIG. 13 is a sectional view of the plate shown in FIG. 12 taken along line 13-13;

FIG. 14 is a sectional view of the plate shown in FIG. 12 taken along line 14-14;

FIG. 15 is a plan view on a reduced scale, of a post operative surgical flat pad with a center hole which can vary in size to that of a patients stoma from a smaller hole shown in solid lines to a larger hole shown in dotted lines; and

FIG. 16 is a sectional view of the pad shown in FIG. 15 taken on line 16-16. This pad is made of disposable expandable polystyrene material and a plastic bag is adhered to the front of the pad for the same functional purposes as in the appliances shown in FIGS. 114.

Referring now to the drawings the substantially weightless back piece or disc shown in FIGS. 1, 2 and 2a is indicated generally as 20. It is made of white, expandable polystyrene in either small or large bead. Although it is repellent to almost all liquids including the fecal and digestive secretions which are emitted from the stoma to which it is constantly subjected when in use, it is also care-free in that it is daily disposable with the pouch.

As seen in cross section in FIG. 2, the disc has a smooth under surface 21 which can be readily molded to the same degree of concavity as that portion of the body to which it will adhere. This substantially strong, yet light plastic is also inherently pliable and is effective as a cushioning device in this vulnerable area.

The upper surface of the disc is provided with a raised rim or curved flange 22 which separates the outer portion 23 from the inner portion 24 thereof. The inner portion is apertured to define a centrally disposed hole 25, the diameter of which will conform to the individual size of stoma it is to service,

For ileostomy and small colostomy conditions, the outer portion 23 is formed in a slightly oval configuration and the ends 26 are provided with indented guide portions 27 which afford access of a retaining belt 28 therein, as shown in FIG. 5. Although the disc will be retained in position by pressure of belt 28 over plate 29, it may also have a self-adhesive backing 36 which adds to the support of the appliance and prevents any discharged secretions from seeping between the disc and the skin. Apertured strips of two-sided pressure sensitive tape cut in identical shape and size to that of the disc are easiest to apply. The patient merely peels off one side of the backing and applies it to the rear surface of the disc. Then the other side of the backing is peeled off before the disc is pressed against the skin.

The disc will thus act to protect the stoma area to cushion it from physical forces as well as to protect the underlying epidermis from deterioration and breakdown. The hole in the center of the disc will vary in diameter to accommodate the stoma of the individual, by increasing in one-eighth inch increments from one-half to 3 inches.

The front piece or overplate 29 illustrated in FIGS. 3 and 4 is made of an injection molded thermoplastic such as nylon and in the same overall sizes as the disc 20 to which it will be fitted. It is also provided with a raised ring or curved flange 30 the inner surface 30a of which embraces the outer surface 22a of the disc ring 22 for a close friction fit, so that when the plate is fitted over the disc the outer edges of the two raised rings will be flush. The disc 20 will not vary in its outer size and shape, but will be provided with various sized inner holes 25 to fit different sized stomas. The plate 29, however, will mainly vary in its outer shape to conform to that of the disc and will be furnished with only two or three different sizes of inner holes 31, the circumference of which is defined by the inner surface 30a of ring 30.

Standard plates may be furnished in white, natural skin color or in a variety of contrasting colors to meet consumer preference, It can be made with a slightly concave or convex surface to conform to that of the disc and will be extremely light in weight, opaque, strong yet flexible, nonabsorbant and repellent to all liquids.

The plate 29 is provided with two slots 32 which overly the indented portions 27 of the disc 20 and through which an elastic or expandable cloth belt 28 is threaded and looped back upon itself, as shown in FIGS. 5, 7 and 8. The ends of the belt may advantageously carry mating sections of Velcro pile 33 and hook 34 self-meshing fasteners which can be repeatedly locked and unlocked to retain the appliance in a firm, secure position against the torso,

The overplate is an essential part of the appliance for it is this piece that holds the appliance to the skin in conjunction with the elastic belt and the adhesive backing strips 36 on the disc. The plate will also serve as a further protection to the stoma area by preventing the polystyrene disc from breaking or twisting. Since the plate is much more rigid than the disc, it will provide resistance and protection against a blow to the stoma region if incurred.

The receptive bags of pouches 35 are made of plastic such as polyethelene and are provided with a flat collar 37 about one-half inch in width. The collar is integrally attached to reinforce this strategic upper rear portion of the bag around the entrance hole and to secure the bag firmly in position between the disc 20 and the overplate 29, as shown in FIGS. 5 and 7. Preformed strips of two-sided pressure sensitive tape 36, cut to the size of the collar are first applied thereto and the other side of the tape is applied to the outer portion 23 of the disc. The adhesive ring is adhered to the outer surface of the collar of the bag and both are then adhered to the disc on the side away from the weavers body.

A standard size of appliance shown in FIGS. 1-5 might have a disc 4 inches long and 3% inches wide with a center hole of 1% inches in diameter. The length and width of the plate would be identical to that of the disc, but its inner hole would be 2% inches in diameter. The disc portions 23, 24 are about one-eighth inch thick beyond which its curved flange 22 projects about one-fourth inch. The plate 29 is only about one-sixteenth inch in thickness and its curved flange 30 projects about three-sixteenth inch to bring it substantially flush with flange 22.

The modifications shown in FIGS. 6--14 differ mainly in the general configuration, shape and size of the disc and overplate and of the inner hole centrally disposed therein, but otherwise embody the same structural features and characteristics of the embodiment illustrated in FIGS. ]l-5. One main difference is that the modified disc is devoid of an inner portion between the raised flange and the center hole.

The appliance shown in FIGS. 6-8 has a horizontally elongated shape and is constructed for special use on patients who have double stomas in a horizontal position. The lower disc has a raised oval ring 22' which terminates the inner periphery of a substantially flat outer portion 23. The inner surface of ring 22' defines a large oval aperture or hole 25' and the ends 26 are provided with cutout or indented portions 27 The nylon or other thermoplastic plate 29 is substantially similar to disc 20 in general size and shape, but its inner oval ring 30, which defines an inner oval aperture 31, is constructed to be press fitted over ring 22'. Slots 32, which register with corresponding indented portions 27, allow both ends of a belt 28 to be threaded therethrough from undemeath and each end to be turned back upon itself so that the Velcro self-meshing fasteners 33, 34 can be locked at the right degree of tension, as shown in FIG. 7.

A standard size of appliance shown in FIGS. 68 might have a disc 6% inches long and 4 inches wide with a center hole of 4 inches-long and 2% inches wide. The length and width of the plate would be identical to that of the disc, but its inner hole would be 4% inches long and 2% inches wide. The appliance shown in FIGS. 10-14 has been specifically constructed to service double stomas in a vertical position or to support temporary colostomy bags, and therefore has a vertically elongated shape.

The lower disc 20" has a raised oval ring 22" which terminates the inner periphery of a substantially flat outer portion 23", and two indented portions 27" in ends 26". The proportions of this disc may have a thickness of one-eighth inch and a ring one-eighth inch wide and one-fourth inch high as seen from FIGS. 9 and 10. The disc and plate of this embodiment are similar to those of FIGS. 68, but made at right angles thereto, i.e., the inner aperture or hole is only 2% inches long and 4 inches wide.

The matching nylon plate 29" has a substantially flat surface which may be about one-sixteenth inch in thickness with a center aperture of 2% inches in length and 4% inches in width, as indicated in FIGS. I214, a raised ring 30" for a press fit over ring 22" and slots 32 for registry with indents 27". Pouches with integral flat collars conforming to the general shape of holes 25 and 25" will be used with appliances shown in FIGS. 614.

A simple post operative surgical appliance consisting of an expandable polystyrene pad 38, a portion of which is shown in FIGS. 15 and 16, may have a center hole 39, ranging from one-half to 3 inches in diameter. Here again a ringed strip of two-sided pressure-sensitive tape 36 may be used to adhere the rear of the pad to the skin and a further ring 36 to adhere the collar of a pouch to the front of the pad.

Two of the many outstanding features of the invention reside in an improved disc which is so economical to make as to become disposable for the first time, thus enhancing the hygienic qualities of the appliance. This disposable disc also acts like a cushion against the skin. Another important feature resides in the preshaped two-sided, pressure-sensitive tapes which are readily available, even when travelling, to adhere the rear surface of the disc to the skin and the pouch collar to the front surface of the disc.

In conclusion it will be seen that the novel appliances disclosed herein have the following advantages over conventional devices:

1. light in weight-all plastic, nonmetallic; 2. economicalnot only per se, but also in eliminating purchase of extraneous supplies such as karaya gum powder, deodorant pellets, cleansers, rubber based glue, glue solvent, etc. 3. more sanitary--daily disposable discs as well as disposable pouches. 4. comfortable-soft, cushionlike disc. 5. more durable than available cheaper conventional appliances. 6. ease of applicationself-adhereing strips, no metal clips, no stretching. 7. ease of control-no running out of glue, pouches, etc., can put extra discs pouches and adhesive strips in a pocket. 8. adaptability to odd type of applications when away from home. 9. more aesthetic--color'preference plates.

I claim: 1

1. An ileostomy and like appliance comprising a comparatively weightless, cushioned, apertured disc adapted to be removably secured to the body of a patient to cover and protect the skin area surrounding a stoma, a first curved flange projecting outwardly from said disc, a complementary apertured plate adapted to be press fitted over said flanged disc, a pouch adapted to be clamped into position between said plate and said disc, a second curved flange disposed on the inner surface of said plate, said second flange embracing said first flange when said plate is press fitted over said disc, and said disc provided with an alternate top, bottom and two ends, said with an indented belt-guide portion disposed on each of said ends, said plate provided with an alternate top, bottom and two ends, and a slot disposed in each of said plate ends, each of said slots registering with one of said indented belt-guide portions.

2. An appliance according to claim 1, including a resilient belt with Velcro hook and pile fasteners on each end thereof, said belt adapted to enter said indented portions, pass through said slots and fold back upon itself to retain said pouch in locked position between said plate and said disc.

3. An appliance according to claim 1, wherein said disc and said plate are horizontally elongated and provided with mating horizontally elongated oval flanges, and said pouch is provided with a horizontally elongated collar conforming to the oval shape of said first flange.

4. An appliance according to claim 1, wherein said disc and said plate are vertically elongated and provided with mating, vertically elongated oval flanges, and said pouch is provided with a vertically elongated collar conforming to the oval shape of said first flange.

S. A method of managing an ileostomy condition comprising the steps of applying one side of a first twosided pressure sensitive tape to the rear surface of a disc, applying the other side of said tape to the skin area surrounding a stoma, applying one side of a second two-sided pressure tape to a pouch, ap-

plying the other side of said second tape to the front surface of said disc, and the press fitting a plate over said pouch-fitting disc to clamp said pouch between said disc and said plate.

6. A method according "to claim 5, including the steps of running a belt through both ends of said plate and then looping each end of said belt back upon itself to press said plate and said pouch firmly against said disc.

7. An ileostomy and like appliance comprising a comparatively weightless, cushioned, apertured disc adapted to be removably secured to the body of a patient to cover and protect the skin area surrounding a stoma, a first curved flange projecting outwardly from said disc, a complementary apertured plate adapted to be press fitted over said flanged disc, a pouch adapted to be clamped into position between said plate and d said disc, said pouch being provided with a top, bottom and two sides, an opening disposed proximate the top of one of said sides, and a flat, substantially rigid collar disposed about said opening, said collar adapted to be clamped between said plate and said disc to afford drainage from said stoma into said pouch, and a strip of two-sided pressure-sensitive tape apertured to conform to the shape of said collar, wherein one side of said strip is adhered to said collar and the other side of the front of said disc. 

1. An ileostomy and like appliance comprising a comparatively weightless, cushioned, apertured disc adapted to be removably secured to the body of a patient to cover and protect the skin area surrounding a stoma, a first curved flange projecting outwardly from said disc, a complementary apertured plate adapted to be press fitted over said flanged disc, a pouch adapted to be clamped into position between said plate and said disc, a second curved flange disposed on the inner surface of said plate, said second flange embracing said first flange when said plate is press fitted over said disc, and said disc provided with an alternate top, bottom and two ends, said with an indented beltguide portion disposed on each of said ends, said plate provided with an alternate top, bottom and two ends, and a slot disposed in each of said plate ends, each of said slots registering with one of said indented belt-guide portions.
 2. An appliance according to claim 1, including a resilient belt with Velcro hook and pile fasteners on each end thereof, said belt adapted to enter said indented portions, pass through said slots and fold back upon itself to retain said pouch in locked position between said plate and said disc.
 3. An appliance according to claim 1, wherein said disc and said plate are horizontally elongated and provided with mating horizontally elongated oval flanges, and said pouch is provided with a horizontally elongated collar conforming to the oval shape of said first flange.
 4. An appliance according to claim 1, wherein said disc and said plate are vertically elongated and provided with mating, vertically elongated oval flanges, and said pouch is provided with a vertically elongated collar conforming to the oval shape of said first flange.
 5. A method of managing an ileostomy condition comprising the steps of applying one side of a first two-sided pressure sensitive tape to the rear surface of a disc, applying the other side of said tape to the skin area surrounding a stoma, applying one side of a second two-sided pressure tape to a pouch, applying the other side of said second tape to the front surface of said disc, and the press fitting a plate over said pouch-fitting disc to clamp said pouch between said disc and said plate.
 6. A method according to claim 5, including the steps of running a belt through both ends of said plate and then looping each end of said belt back upon itself to press said plate and said pouch firmly against said disc.
 7. An ileostomy and like appliance comprising a comparatively weightless, cushioned, apertured disc adapted to be removably secured to the body of a patient to cover and protect the skin area surrounding a stoma, a first curved flange projecting outwardly from said disc, a complementary apertured plate adapted to be press fitted over said flanged disc, a pouch adapted to be clamped into position between said plAte and d said disc, said pouch being provided with a top, bottom and two sides, an opening disposed proximate the top of one of said sides, and a flat, substantially rigid collar disposed about said opening, said collar adapted to be clamped between said plate and said disc to afford drainage from said stoma into said pouch, and a strip of two-sided pressure-sensitive tape apertured to conform to the shape of said collar, wherein one side of said strip is adhered to said collar and the other side of the front of said disc. 